(119 days)
The PTFE Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.
The Enpath Medical PTFE Peelable Introducer kit consists of a disposable needle, a disposable syringe, a guidewire, and a peelable introducer set consisting of a dilator and sheath with integrated proximal handles. The Introducer is available in various lengths in 3.5F through 7F (micro) and 7F through 16.5F (macro). The dilator is designed to be delivered over a 0.018" guidewire (micro) up to a 0.038" guidewire (macro). The dilator and hub is constructed of high density polyethylene. The outer sheath and handle is constructed of PTFE and TPX. The inner dilator and outer sheath are radiopaque so that they are visible under fluoroscopy. The hub of the dilator has a spin lock design that connects to the luer of the sheath when rotated. The Percutaneous Introducer sheath has a "tear-away" feature which allows the user to remove the sheath without removing the inserted catheter or pacing lead. The kit is packaged in a tray and placed into a poly-Tyvek pouch and sealed.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PTFE Peelable Introducer:
This document is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device. It focuses on non-clinical testing for equivalence rather than establishing new clinical effectiveness or performance criteria for a novel device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device functions in a safe and effective manner | Test results verify that the device performs per specification requirements and is equivalent to the predicate device. |
| Device performs per specification requirements | Test results confirm the device performs as intended. |
| Device is equivalent to the predicate device without creating additional risk to the patient or user | Substantially equivalent to the currently marketed Enpath Medical Percutaneous Introducers based on a comparison of the indications for use and the technological characteristics. |
| Functional and dimensional testing of the PTFE Peelable Introducer meets requirements | Performance testing included functional and dimensional testing. (Specific criteria not detailed, but states it met them). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "Performance Testing: The performance testing for this device included testing to verify that the device continues to functions in a safe and effective manner." This implies a physical testing or engineering study, not a clinical trial with human subjects.
- Data Provenance: The testing was "non-clinical." This means it was likely laboratory or bench testing performed by the manufacturer, Enpath Medical, probably in the US where the company is based. It is retrospective in the sense that it's based on internal validation against predefined specifications rather than a prospective trial with patient enrollment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. As this was non-clinical performance testing, there was no "ground truth" to be established by clinical experts in the traditional sense. The "ground truth" was likely the engineering specifications and performance characteristics of the predicate device.
4. Adjudication Method for the Test Set
- Not Applicable. There was no human reading or interpretation of results that would require an adjudication method. The testing involved objective measurements against specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document explicitly states: "Summary of Clinical Testing: No clinical evaluations of this product have been performed." Therefore, no MRMC study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not Applicable. This is a physical medical device (an introducer kit), not an AI algorithm or software. Therefore, the concept of "standalone performance" for an algorithm does not apply. The performance assessed was the physical device itself.
7. Type of Ground Truth Used
- Engineering Specifications / Predicate Device Characteristics. For the non-clinical testing, the ground truth was the established engineering specifications for the device and the performance characteristics of the predicate device (Enpath Medical, Inc. Percutaneous Introducer K000824). The goal was to show the new device met its own specifications and performed equivalently to the predicate.
8. Sample Size for the Training Set
- Not Applicable. There was no "training set" as this device is not an AI/ML algorithm. The testing involved physical device samples.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there was no training set, this question is irrelevant. The "ground truth" for the non-clinical testing (not training) was based on established engineering standards and comparison to a legally marketed predicate device.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).